Multicenter Cardiac Decision Impact Study in People With Breast Cancer

NCT07703033 | Recruiting DMC

• 2 other identifiers: NL010708101080983
• Study Type: interventional
• Target: 1,000
• Locations: 4 countries
• Sites: 5

Brief Summary

Background: Breast cancer is the most common cancer in women, and advances in early detection and treatment have led to steadily improved survival rates. Today, nearly 80% of breast cancer survivors are over 50 years of age. With longer survival, comes a greater burden of chronic disease, particularly cardiovascular disease (CVD), which is more common in breast cancer survivors than in the general population. This elevated risk is driven by treatment-related effects, such as chemotherapy- and radiotherapy-induced cardiotoxicity, metabolic changes including (therapy-associated) weight gain, and shared lifestyle risk factors such as obesity and physical inactivity. In routine clinical care, approximately 65% of breast cancer patients undergo local radiotherapy (RT) and will receive a planning computed tomography (CT) scan. These scans, while intended for RT planning, also capture valuable information on coronary artery calcifications (CAC), a well-established marker risk factor of CVD risk. The ARTILLERY-CarDI study is a multinational decision impact trial which will evaluate calculating CAC-based CVD risk (Agatston score) and communicating personalized, risk-based management recommendations to breast cancer patients. Aims and outcomes: In this study, CVD risk is estimated based on the manual CAC (Agatston) score using RT planning CT scans and a corresponding CVD risk-based recommendation is provided to breast cancer patients. The main aim of this study is to disclose this estimated CVD risk to treating physicians and patients and investigate how this risk affects:

1. 1.breast cancer treatment (retrospectively) and cardiovascular care (i.e., no further action, recommendation for lifestyle changes, referral to a cardiologist or general practitioner (GP)), and
2. 2.patients' satisfaction with their decision to receive their estimated CVD risk and the corresponding CVD risk-based management.

Conditions

Breast Cancer; Cardiovascular (CV) Risk; Coronary Artery Calcifications

Keywords

Radiotherapy planning CT scans; Decision impact trial; patient reported outcomes; decisional conflict; satisfaction with decision

Outcome Measures

Primary Outcomes (1)

• Changes in breast cancer treatment decisions (retrospective) and CVD risk- based management (cardiovascular care), and patients' satisfaction with their decision to receive personalized CVD-risk estimation and CVD risk-based management.

  From enrollment to 6 months after the personalized CVD-risk (based on coronary artery calcifications, Agatston score) disclosure.

Study Arms (1)

Estimating CVD-risk by measuring coronary artery calcifications (Agatston score) on routine CT scans

EXPERIMENTAL

Other: Measuring coronary artery calcifications (Agatston score) using routine radiotherapy planning CT scans and communicating the associated risk of cardiovascular disease to the patient.

Interventions

Measuring coronary artery calcifications (Agatston score) using routine radiotherapy planning CT scans and communicating the associated risk of cardiovascular disease to the patient. OTHER

The cardiovascular disease (CVD) risk will be estimated based on the amount of coronary artery calcifications (Agatston score) using routine radiotherapy planning CT scans. Subsequently, this estimated CVD risk and the corresponding disease management will be disclosed to the patient.

Estimating CVD-risk by measuring coronary artery calcifications (Agatston score) on routine CT scans

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with breast cancer or ductal carcinoma in situ
• Planned for radiotherapy
• From 35 years of age onwards

You may not qualify if:

• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (5)

RegionH

Copenhagen, Denmark

NOT YET RECRUITING

LMU University Hospital

München, Germany

NOT YET RECRUITING

Amsterdam University Medical Center

Amsterdam, Netherlands

NOT YET RECRUITING

St. Antonius Hospital

Utrecht, Netherlands

RECRUITING

Champalimaud Foundation

Lisbon, Portugal

NOT YET RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Verkooijen

CONTACT

+31 (0) 88 755 6689; cardi@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: July 14, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

DE (1); NL (2); DK (1); PT (1)